Self-screening for STI and HPV

HerSwab

Abstract:

Cervical Cancer and Pelvic Inflammatory Disease (PID) are two diseases affecting women’s health that could be greatly reduced through prevention practices and regular screening. For myriad reasons, many women, even those with ready access to services, are not getting screened. Self-screening using a novel device by Eve Medical can bridge the gap in the healthcare system for under-screened populations.

Background:

Cervical cancer accounts for 12% of all cancers afflicting women worldwide. It is particularly prevalent in developing countries, where it is the most common cancer in women. According to the World Health Organization (WHO), there are 528,000 cases of cervical cancer every year globally, resulting in 266,000 deaths. Most cervical cancer cases are caused by high risk strains of the Human Papillomavirus infection (HPV).

Likewise, the WHO estimates that one million sexually transmitted infections (STIs) are contracted around the world every 24 hours. Untreated, STIs can lead to pelvic inflammatory disease (PID), which can damage the female reproductive organs and lead to infertility. In high income countries, the annual rate of PID has been reported to be as high at 10-20 per 1000 women of reproductive age. The rate in developing countries is difficult to determine, as screening services and public health care are less available. In Canada, there are 100,000 cases of symptomatic PID every year, but the Public Health Agency of Canada estimates that up to 2/3 of cases go unrecognized, so the total number of cases is underreported.

Prevention

The incidence rate of both cervical cancer and PID can be greatly reduced through preventative measures, including safe sex practices, vaccines and regular screening.

HPV is the most common STI, although in most cases it causes no disease. However, high risk strains of HPV can sometimes cause cervical cancer. Anyone who is sexually active can contract HPV. There is a vaccine available to protect against diseases caused by certain strains of HPV. It is recommended that all boys and girls receive the vaccine at age 11 or 12, but anyone who missed getting the vaccine at those ages can get a catch-up vaccine up to the ages of 21 for males and 26 for females. Safe sex practices, such as using condoms and limiting the number of sexual partners can also limit the spread of the virus.

Although PID can be caused by a number of bacteria, it is most often caused by the STIs, gonorrhea or chlamydia. Safe sex practices are also indicated for the prevention of STIs.

Even with safer sex and vaccines, regular cervical screening (Pap test) is recommended to identify pre-cancerous changes to the cells of the cervix. Once detected, these changes (called precursor lesions) can be treated, preventing the cervical cancer from developing. An HPV DNA test may also be used with a Pap test to detect certain HPV types on the cervix.

Screening for chlamydia and gonorrhea is also recommended through a swab of the genital area or urine sample. Once detected, chlamydia will be treated with antibiotics and the infection should clear up in about 7 days. Gonorrhea can be treated with a therapy of two antibiotics.

1/3 of women in Canada do not screen regularly

Although screening is indicated for women ages 25-69, about 1/3 of women in Canada do not screen regularly. The reason for avoiding the test could be related to time, access to a family doctor or healthcare services (remote areas) and general discomfort with the testing process.

In developing countries, access to screening is further limited due to economic and social issues, including limited testing facilities, resources and competing health concerns.

Self-Screening

Jessica Ching of Eve Medical and Nancy Seto began designing solutions to address this deficiency in screening rates, leading to the development of a specially designed self-collection device called HerSwabTM. This device allows women to collect their vaginal samples in a more private and convenient way, overcoming barriers such as lack of time, healthcare access or embarrassment that would have otherwise stopped them from screening regularly, or screening at all.

Eve Kit integrates HerSwabTM with a full STI and HPV screening service that includes laboratory testing and result delivery through an online portal. Users simply need to order the kit online, self-collect a sample upon receiving the kit, send the sample on the pre-addressed box to accredited lab partners and check their results through a portal. With Eve Kit, women can now screen easily for the infections that can lead to cervical cancer and pelvic inflammatory disease from the convenience of home.

At the end of this year, the kit will be available to purchase online at evekit.com.

Performance and Acceptance

Eve Medical began evaluating HerSwabTM with small focus groups, where the acceptability of the device and self-sampling was measured. Clinical trials were subsequently conducted to evaluate performance.

In a study of 189 women published in February 2016, self-collected samples were compared with physician collected samples, showing an agreement of 94.7% (κ = 0.64) for chlamydia and of 98.4% (κ = 0.56) for gonorrhea. The study concluded that HerSwabTM could be used to diagnose chlamydia and gonorrhea (Arias et al., 2016). Completed surveys from this patient group found that 93% of women found the HerSwabTM device very easy or easy to use, 98% found the instructions easy to follow, and 81% of women preferred collecting their own sample compared to the physician.

81% of women preferred collecting their own sample compared to the physician

HerSwabTM continues to participate in international pilot projects to improve screening outreach. HerSwabTM is CE Marked and Health Canada Approved for use in Canada and the European Union. It is also available for research use in other jurisdictions. Eve Medical is an ISO13485-certified company.

The cost of the Eve Kit can be covered under a Health Spending Account (HSA) in Canada but there is interest in integrating self-sampling into wider public health systems (particularly to target underserved populations). Eve Medical is working with several organizations globally to pilot this type of screening alternative and is currently participating in projects in Guatemala, Peru and Colombia. The goal is to have it be more widely available through such initiatives in the future.

Conclusion and Significance:

Nowadays, there is more evidence supporting the idea that self-sampling is a good option for cervical cancer screening, particularly for women who face barriers to screening. Recent studies show that self-sampling is preferred by under-screened women or women who do not participate in regular cervical screening, and that it has good agreement with clinician sample collection. Similar findings suggest that self-sampling is an acceptable alternative for STI screening as well, although rigorous economic evaluations need to be performed for policy implementation of this new screening methodology.

The significance for the developing world could mean that women who previously had no access to screening due to remote locations and insufficient healthcare facilities can take control of their own health. If adequate testing facilities and access to follow-up treatment can be assured, the incidence of cervical cancer and PID can be greatly reduced.

References:

American Cancer Society, 2014. Cervical Cancer Prevention. http://www.cancer.org/cancer/cervicalcancer/detailedguide/cervical-cancer-prevention.

Arbyn, M., & Castle, P. E. (2015). Offering self-sampling kits for HPV testing to reach women who do not attend in the regular cervical cancer screening program. Cancer Epidemiology Biomarkers & Prevention, 24(5), 769-772.

Arias, M., Jang, D., Gilchrist, J., Luinstra, K., Li, J., Smieja, M., & Chernesky, M. A. (2016). Ease, Comfort, and Performance of the HerSwab Vaginal Self-Sampling Device for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Sexually transmitted diseases, 43(2), 125-129.

Cancer Quality Council of Ontario. http://www.csqi.on.ca/by_patient_journey/screening/cervical_screening_participation/

International Agency for Research on Cancer: All Cancers (excluding non-melanoma skin cancer) Estimated Incidence, Mortality and Prevalence Worldwide in 2012. Accessed 8 December 2015. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx

CDC (2016). Human Papillomavirus (HPV). Centers for Disease Control and Prevention [website]. Accessed via: http://www.cdc.gov/std/hpv/stdfact-hpv.htm

Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer; 2013. Accessed via: http://globocan.iarc.fr.

Moore, Suzanne, Sebastien Antoni, Amy Colquhoun, Bonne Healy, Lis Ellison-Loschmann, John D. Potter, Gail Garvey and Freddie Bray (2015). Cancer incidence in indigenous people in Australia, New Zealand, Canada and the USA: a comparative population-based study. The Lancet, Vol. 16, No. 15, p1483-1492. Accessed via: http://www.thelancet.com/action/showFullTextImages?pii=S1470-2045%2815%2900232-6

Oldham, R. K., & Dillman, R. O. (Eds.). (2009). Principles of cancer biotherapy. Springer Science & Business Media, 194.

Paudyal, P., Llewellyn, C., Lau, J., Mahmud, M., & Smith, H. (2015). Obtaining Self-Samples to Diagnose Curable Sexually Transmitted Infections: A Systematic Review of Patients’ Experiences. PloS one, 10(4), e0124310.

Public Health Agency of Canada, 2013. http://www.phac-aspc.gc.ca/std-mts/sti-its/cgsti-ldcits/section-4-4-eng.php

Shepherd, Suzanne Moore (2015). Pelvic Inflammatory Disease. Medscape [website]. Accessed via: http://emedicine.medscape.com/article/256448-overview#a2

Sultana, F., Mullins, R., English, D. R., Simpson, J. A., Drennan, K. T., Heley, S., … & Gertig, D. M. (2015). Women’s experience with home-based self-sampling for human papillomavirus testing. BMC cancer, 15(1), 1.

Verdoodt, F., Jentschke, M., Hillemanns, P., Racey, C. S., Snijders, P. J. F., & Arbyn, M. (2015). Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: A systematic review and meta-analysis of randomised trials. European Journal of Cancer, 51(16), 2375-2385.

WHO (2015) http://www.who.int/mediacentre/factsheets/fs110/en/

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Violeta Cobo
Violeta manages Eve Medical’s customer relationships in Latin America, Spain and France. She has cancer research experience at the Université Pierre et Marie Curie in Paris, and has worked internationally in customer service roles. Violeta is a graduate of Universidad Autónoma de Madrid in Biology and focused her last two years around Cognitive Sciences while she was studying abroad in France and Canada. Motivated by the idea of working for meaningful cause, Violeta left the academia and started working at Eve Medical, a company where technology innovation and great ideas meet to create a better healthcare experience.
Janica Echavez
Janica is an incoming third year Mechanical Engineering student at the University of Calgary with a Minor in Mechatronics. She is interested in the intersection between technology and women empowerment. This, along with the curiosity to work on a start-up environment is what drew her to Eve Medical. She is currently a summer intern assisting in community development and public relations.
Jessica Ching
Jessica Ching is an industrial designer responsible for product development and the overall direction of Eve Medical. She has worked previously in product development and manufacturing liaison roles for Herman Miller, Umbra and Telus. Following her passion to integrate design and healthcare, Jessica co-founded Eve Medical to develop Eve Kit after graduating from the Industrial Design program at OCAD University. She is a grateful recipient of the Martin Walmsley Fellowship for Technological Entrepreneurship, and was named one of the Globe & Mail's Top 12 Canadian Innovators. She holds a BA in International Development from McGill University and she is also a graduate of OCAD University.

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